SHARD N-TW2713

GUDID 00814639025422

SHARD Hypodermic Needles 27G*13mm (1/2") Thin wall.

APPLIED DENTAL, INC.

Medication transfer needle, non-filtering/non-vented

• Primary Device ID: 00814639025422
• NIH Device Record Key: a2b250c4-76dd-4768-8991-b6d0a6a27c84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHARD
• Version Model Number: N-TW2713
• Catalog Number: N-TW2713
• Company DUNS: 017524666
• Company Name: APPLIED DENTAL, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814639025422 [Primary]
GS1	10814639025429 [Package]; Package: box [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072739

FDA Product Code

• MEG: Syringe, Antistick

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: 2022-06-08
• Device Publish Date: 2022-05-31

On-Brand Devices [SHARD]

• 10814639025078: SHARD Premium+ Dermal Curettes, Stainless Steel, Sterile. 2.0mm
• 10814639025207: Disposable Stainless Steel Biopsy Punch Sterile. 8.0mm.
• 00814639025194: Disposable Stainless Steel Biopsy Punch Sterile. 6.0mm.
• 10814639025184: Disposable Stainless Steel Biopsy Punch Sterile. 5.0mm.
• 10814639025177: Disposable Stainless Steel Biopsy Punch Sterile. 4.0mm.
• 10814639025160: Disposable Stainless Steel Biopsy Punch Sterile. 3.5mm.
• 10814639025153: Disposable Stainless Steel Biopsy Punch Sterile. 3.0mm.
• 10814639025146: Disposable Stainless Steel Biopsy Punch Sterile. 2.5mm.
• 10814639025139: Disposable Stainless Steel Biopsy Punch Sterile. 2.0mm.
• 00814639025125: Disposable Stainless Steel Biopsy Punch Sterile. 1.5mm.
• 10814639025115: SHARD Premium+ Dermal Curettes, Stainless Steel, Sterile. 7.0mm
• 10814639025108: SHARD Premium+ Dermal Curettes, Stainless Steel, Sterile. 5.0mm
• 10814639025092: SHARD Premium+ Dermal Curettes, Stainless Steel, Sterile. 4.0mm
• 10814639025085: SHARD Premium+ Dermal Curettes, Stainless Steel, Sterile. 3.0mm
• 10814639025269: SHARD Disposable Surgical Chisel Blades , Sterile. Size 91.
• 10814639025252: SHARD Disposable Surgical Chisel Blades , Sterile. Size 90.
• 10814639025221: SHARD Disposable Surgical Stainless Scalpels, Sterile. Size 12.
• 10814639025214: SHARD Disposable Surgical Stainless Scalpels, Sterile. Size 15-C.
• 10814639025061: SHARD Disposable Surgical Chisel Blades , Sterile. Size 69.
• 10814639025023: SHARD Disposable Surgical Chisel Blades , Sterile. Size 67.
• 10814639025016: SHARD Disposable Surgical Chisel Blades , Sterile. Size 65.
• 10814639025009: SHARD Disposable Surgical Chisel Blades , Sterile. Size 64.
• 10814639024996: SHARD Disposable Surgical Chisel Blades , Sterile. Size 62.
• 10814639024026: SHARD Disposable Premium Surgical Stainless Scalpels, Sterile. Size 15.
• 10814639024019: SHARD Disposable Premium Surgical Stainless Scalpels, Sterile. Size 12.
• 10814639024002: SHARD Disposable Premium Surgical Stainless Scalpels, Sterile. Size 11.
• 10814639023999: SHARD Disposable Premium Surgical Stainless Scalpels, Sterile. Size 10.
• 10814639023074: SHARD Disposable Surgical Chisel Blades , Sterile. Size 61.
• 10814639022145: SHARD Disposable Surgical Stainless Scalpels, Sterile. Size 20.
• 10814639022138: SHARD Disposable Surgical Stainless Scalpels, Sterile. Size 15.
• 10814639022121: SHARD Disposable Surgical Stainless Scalpels, Sterile. Size 11.
• 10814639022114: SHARD Disposable Surgical Stainless Scalpels, Sterile. Size 10.
• 00814639022018: SHARD Disposable Premium Surgical Stainless Blades, Sterile. Size 15-C.
• 00814639022001: SHARD Disposable Premium Surgical Stainless Blades, Sterile. Size 15.
• 00814639021998: SHARD Disposable Premium Surgical Stainless Blades, Sterile. Size 12.
• 00814639021981: SHARD Disposable Premium Surgical Stainless Blades, Sterile. Size 11.
• 00814639021974: SHARD Disposable Premium Surgical Stainless Blades, Sterile. Size 10.
• 00814639025682: Reusable Handle of Surgical Chisel Blades for Size M31-M69. Stainless Steel, Autoclavable.
• 00814639025033: Reusable Handle for Microsurgical Blade #M90-91 . Stainless Steel.
• 10814639025474: SHARD Hypodermic Needles 27G*30mm (1.18") Thin wall.
• 00814639025422: SHARD Hypodermic Needles 27G*13mm (1/2") Thin wall.