FDA.report

Henry Schein

Primary DI
00304040091081
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701113
Catalog number
5701113
Device description
OR Towels 17x27 Non-Sterile Blue 100% Cotton Pouch Latex Free
Published
2020-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FRLFIBER, MEDICAL, ABSORBENT

Product Code Classifications

CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040091081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040091081003040400910813040400910810304040091081

GMDN Terms

TermDefinition
Dry medical towel/wipe, single-useA dry fabric intended to be used to wipe or dry a patient’s intact skin (not related to wound care), clean medical devices/equipment (e.g., endoscopes, ultrasound systems), and/or clean the general environment (e.g., fluid spill). It may be moistened (e.g., with water or used together with disinfectant/cleaning solutions) however no solutions are included. Some devices may be provided sterile, or designed to be sterilized, for use under sterile conditions [e.g., within an operating room (OR)]; devices intended for non-surgical applications may be provided and used in a non-sterile state. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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

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