Tech Medical Services

GUDID 00851695005128

Endo Pouch with Introducer

TECHMEDICAL SERVICES, INC.

Surgical tissue/fluid collection bag, sterile Surgical tissue/fluid collection bag, sterile Surgical tissue/fluid collection bag, sterile Surgical tissue/fluid collection bag, sterile Surgical tissue/fluid collection bag, sterile Surgical tissue/fluid collection bag, sterile Surgical tissue/fluid collection bag, sterile Surgical tissue/fluid collection bag, sterile Surgical tissue/fluid collection bag, sterile Surgical tissue/fluid collection bag, sterile Surgical tissue/fluid collection bag, sterile Surgical tissue/fluid collection bag, sterile Surgical tissue/fluid collection bag, sterile Surgical tissue/fluid collection bag, sterile Surgical tissue/fluid collection bag, sterile Surgical tissue/fluid collection bag, sterile Surgical tissue/fluid collection bag Surgical tissue/fluid collection bag Surgical tissue/fluid collection bag Surgical tissue/fluid collection bag Surgical tissue/fluid collection bag Surgical tissue/fluid collection bag Surgical tissue/fluid collection bag Surgical tissue/fluid collection bag Surgical tissue/fluid collection bag Surgical tissue/fluid collection bag Surgical tissue/fluid collection bag

• Primary Device ID: 00851695005128
• NIH Device Record Key: f61439d9-085f-48ae-a721-27296488f636
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tech Medical Services
• Version Model Number: TM3000I
• Company DUNS: 556093219
• Company Name: TECHMEDICAL SERVICES, INC.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851695005128 [Primary]
GS1	10851695005125 [Package]; Package: Inner [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103510

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

[00851695005128]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-13

On-Brand Devices [Tech Medical Services]

• 00851695005654: Monopolar Disposable Cautery Probe J-Hook
• 00851695005630: Veress Needle
• 00851695005616: Curved Wireless Probe Cover with Cradle and Battery
• 00851695005609: Probe Cover with Probe Holder and Probe Battery Included
• 00851695005593: Curved Universal Wireless Probe Cover with Probe Cradle
• 00851695005524: Reusable Probe 10mm/33cm
• 00851695005494: Curved Probe Cover with Cradle
• 00851695005487: Curved Universal Wireless Probe Cover
• 00851695005456: Straight Universal Wireless Probe with Cradle
• 00851695005449: Straight Wireless Probe Cover
• 00851695005425: Monopolar Spatula Probe
• 00851695005371: Disposable Suction Irrigation Probe
• 00851695005357: Monopolar Disposable Cautery Probe Spatula
• 10851695005262: Scope warmer which pre-warms multiple endoscopes
• 10851695005255: Scope warmer which pre-warms multiple endoscopes
• 00851695005180: Endo Pouch with Endo Wire
• 00851695005128: Endo Pouch with Introducer
• 00851695005111: Detachable Endo Pouch
• 00851695005104: Detachable Endo Pouch 3"x6"
• 00851695005098: Detachable Endo Pouch 5x7
• 00851695005074: Wireless Gamma Probe Cover with Holder
• 00851695005036: Scope warmer which pre-warms multiple endoscopes
• 00851695005012: Wired Gamma Probe Cover
• 10851695005026: Suction Irrigation Set (Dual Spike)
• 10851695005910: Monopolar L-hook Probe for Suction/Irrigation Set
• 00851695005869: Trocar Site Closure Device
• 10851695005835: Monopolar Disposable Cautery Probe L-hook
• 10851695005798: Endo Pouch with Suture Tie, 5"x7"
• 10851695005767: Endo Pouch with Suture Tie, 3"x6"
• 10851695005743: Endo Pouch with Memory Wire, 3"x6"
• 00851695005708: Dual Irrigation Pump, 1000ml
• 00851695005685: Single Irrigation Pump, 1000ml
• 10851695005576: Smoke Evacuation Tubing
• 10851695005293: Straight Grasper, 5mm/33cm
• 10851695005286: Maryland Dissecting Grasper, 5mm/33cm
• 10851695005279: Endo Pouch with Introducer, 5"x7"
• 10851695005163: Monopolar Needle Probe for Suction/Irrigation Set
• 10851695005088: Disposable Suction Irrigation Probe, 5mm/45cm