Home GUDID 00815849020108 Custom Medical Specialties, Inc.
Primary DI 00815849020108
Brand Custom Medical Specialties, Inc.
Company CUSTOM ASSEMBLIES, INC.
Model CMS-1637
Device description Needle Holder - Sterile
Published 2016-11-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name HXK Holder, Needle; Orthopedic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HXK Holder, Needle; Orthopedic Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00815849020566 Package GS1 25 In Commercial Distribution 00815849020108 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 00815849020566 00815849020566 815849020566 0815849020566 00815849020108 00815849020108 815849020108 0815849020108
GMDN Terms# Term, Definition table Term Definition Sharp surgical instrument counting tray/pad, single-use A device intended to be used in the operating room (OR) by staff to maintain the count of various sharp surgical instruments (e.g., needles, blades, scissors) to prevent instruments from being inadvertently left in a patient; it may in addition be used for temporary storage of instruments during surgery. The counter is usually flat when in use and employs magnetism, foam rubber, or some other mechanism to hold the counted objects in place. This is a single-use device.
Regulatory Flags# DUNS number 948904735 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00815849020160 Custom Medical Specialties, Inc. CMS-510 2016-11-21 00815849020177 Custom Medical Specialties, Inc. CMS-515 2016-11-21 00815849021556 Custom Medical Specialties, Inc. CMS-1637-NS 2016-11-21 00815849021839 Custom Medical Specialties, Inc. CMS-586 2016-11-21 00815849024021 Custom Medical Specialties, Inc. CMS-2732-R4 2023-09-14 00815849024571 Custom Medical Specialties, Inc. CMS-6314-R6 2023-09-14 00815849023369 Custom Medical Specialties, Inc. CMS-1235 2023-09-13 00815849023390 Custom Medical Specialties, Inc. CMS-1238 2023-09-13 00815849023406 PG-1000 PG-1000 2023-09-13 00815849023437 Custom Assemblies, Inc. CMS-2012-R3 2023-09-13 00815849023444 Custom Assemblies, Inc. CMS-8322-R1 2023-09-13 00815849023451 Custom Medical Specialties, Inc. CMS-5650-R2 2023-09-13 00815849023468 Custom Medical Specialties, Inc. CMS-6382 2023-09-13 00815849023475 Custom Medical Specialties, Inc. CMS-6439-C 2023-09-13 00815849023482 MPM MPM-312-R1 2023-09-13 00815849023499 Custom Medical Specialties, Inc. CMS-1911-R3 2023-09-13 00815849023505 MPM MPM-295 2023-09-13 00815849023512 Custom Medical Specialties, Inc. CMS-2450-R4 2023-09-13 00815849023529 Custom Medical Specialties, Inc. CMS-4439-R5 2023-09-13 00815849023536 Custom Medical Specialties, Inc. CMS-6803-R1 2023-09-13
Other Devices Sharing Product Codes#