AccessGUDID - DEVICE: E.M. ADAMS CO, INC (10840200320709)

GUDID

Device Identifier (DI) Information

Brand Name: E.M. ADAMS CO, INC
Version or Model: EP60603XXXL-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: E.M. ADAMS, INC.

Primary DI Number: 10840200320709
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001403807 *Terms of Use

Device Description: PELVIC HOLDER

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62482	Limb/torso/head restraint, reusable	A non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMQ	Restraint, Protective

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K971948	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 32" X 34" BODY/1.5" X 130" STRAP/1.5" X 100" STRAP

Device Record Status

Public Device Record Key: 7f914828-848a-4c15-b58b-e5e200ecc62d
Public Version Date: July 25, 2022
Public Version Number: 1
DI Record Publish Date: July 17, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50840200320691	6	10840200320709		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 7724610532
Email: emadams@emadamsco.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES