AccessGUDID - DEVICE: ALLCARE (00182921000199)

GUDID

Device Identifier (DI) Information

Brand Name: ALLCARE
Version or Model: AL1818-800
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALLCARE, INC

Primary DI Number: 00182921000199
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 800
Labeler D-U-N-S® Number*: 362187580 *Terms of Use

Device Description: LAPAROTOMY SPONGE,18"X18", 5/PK, X-RAY DETECTABLE, COTTON, PRE-WASHED, NON-STERILE, 40PK/CASE

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
38496	Radiopaque woven surgical sponge	A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDY	Gauze/Sponge, Internal, X-Ray Detectable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 601c4f02-46d5-4312-88a5-090043874774
Public Version Date: January 25, 2022
Public Version Number: 1
DI Record Publish Date: January 17, 2022