Home GUDID 10827002165547 Cook
Primary DI 10827002165547
Brand Cook
Company COOK INCORPORATED
Model G16554
Catalog number J-PCB-220902
Device description Offset P.C.B. Paracervical Block Needle
Published 2016-11-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FBK endoscopic injection needle, gastroenterology-urology
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10827002165547 Package GS1 5 In Commercial Distribution 00827002165540 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10827002165547 10827002165547 00827002165540 00827002165540 827002165540 0827002165540
GMDN Terms# Term, Definition table Term Definition Rigid endoscopic cannula, single-use A sterile, rigid, single-lumen device intended to be used during endoscopy to provide cannulation for the instillation or aspiration of fluid to/from a targeted area of the body (e.g., introduction of drug solutions, a contrast medium or other kinds of fluid/solution into a body cavity for diagnosis and treatment) or for the introduction/accommodation of another device. It will typically be made of high-grade stainless steel and/or other durable materials. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in dark, dry, cool place.
Regulatory Flags# DUNS number 042823948 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10850002461388 InjecSURE ® Carbon Medical Technologies, Inc. FBK 2026-04-09 10850002461395 InjecSURE ® Carbon Medical Technologies, Inc. FBK 2026-04-09 10850002461418 InjecSURE ® Carbon Medical Technologies, Inc. FBK 2026-04-09 10850002461425 InjecSURE ® Carbon Medical Technologies, Inc. FBK 2026-04-09 00850002461404 InjecSURE ® Carbon Medical Technologies, Inc. FBK 2026-04-09 00850002461435 InjecSURE® Carbon Medical Technologies, Inc. FBK 2026-04-09 03600040326893 BoNee Coloplast A/S FBK 2025-05-20 03600040974841 BoNee Coloplast A/S FBK 2025-05-20 00816734023365 EZ-Ject DIVERSATEK HEALTHCARE, INC. FBK 2024-07-18 00816734023372 EZ-Ject DIVERSATEK HEALTHCARE, INC. FBK 2024-07-18 00816734023389 EZ-Ject DIVERSATEK HEALTHCARE, INC. FBK 2024-07-18 00816734023396 EZ-Ject DIVERSATEK HEALTHCARE, INC. FBK 2024-07-18 00816207021256 AcuJect Flex ENDO-THERAPEUTICS, INC. FBK 2023-07-11 00860008483720 Uro-N Cystoscope UROVIU CORP. FBK 2022-12-16 00724995219185 FastFlo US Endoscopy FBK 2022-11-09 00724995219192 FastFlo US Endoscopy FBK 2022-11-09 00724995219208 FastFlo US Endoscopy FBK 2022-11-09 00724995219215 FastFlo US Endoscopy FBK 2022-11-09 00724995180881 NA US Endoscopy FBK 2020-04-02 00724995180898 NA US Endoscopy FBK 2020-04-02 00724995180904 NA US Endoscopy FBK 2020-04-02 00724995180911 NA US Endoscopy FBK 2020-04-02 00724995180928 NA US Endoscopy FBK 2020-04-02 00724995180935 NA US Endoscopy FBK 2020-04-02 00724995180942 NA US Endoscopy FBK 2020-04-02 00724995180850 Articulator US Endoscopy FBK 2020-04-01 00724995180867 Articulator US Endoscopy FBK 2020-04-01 00724995180874 Articulator US Endoscopy FBK 2020-04-01 00724995180782 iSnare US Endoscopy FBK 2020-03-19 00724995180799 iSnare US Endoscopy FBK 2020-03-19
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