TKMD

GUDID 16934841570365

The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with one-hand operation by pressing the sheath either with the finger or thumb, or by surface activation. The locking mechanism is positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner the flexibility to adjust the sheath to its desired position for use.

Anhui Tiankang Medical Technology Co., Ltd.

Hypodermic needle, single-use

• Primary Device ID: 16934841570365
• NIH Device Record Key: 9837136a-3a84-48cf-aaf0-f2a6a78dfd53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TKMD
• Version Model Number: TKSN
• Company DUNS: 527035248
• Company Name: Anhui Tiankang Medical Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934841570368 [Primary]
GS1	16934841570365 [Package]; Contains: 06934841570368; Package: box [100 Units]; Discontinued: 2021-02-04; Not in Commercial Distribution
GS1	66934841570360 [Package]; Package: carton [20 Units]; Discontinued: 2021-02-04; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191644

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-12
• Device Publish Date: 2021-02-04

On-Brand Devices [TKMD]

• 16934841570006: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841560007: The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow
• 16934841570532: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570525: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570518: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570501: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570495: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570488: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570471: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570464: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570457: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570440: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570433: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570426: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570419: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570402: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570396: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570389: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570372: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570365: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570358: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570341: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570334: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570327: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570310: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570303: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570297: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570280: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570273: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570266: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570259: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570242: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570235: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570228: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570211: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570204: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570198: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570181: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570174: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570167: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570150: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570143: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570136: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570129: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570112: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570105: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841570099: The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the
• 16934841565149: The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow
• 16934841565132: The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow
• 16934841565125: The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow