Encompass

Primary DI
10612899001982
Brand
Encompass
Company
Encompass Group, L.L.C.
Model
48005
Device description
WASHCLOTH, 12X12, 500EA TS WASHCLOTH, BLUE DIAMOND, DRC, 50/BG, 10 BG/CS NONWOVEN
Published
2022-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FRLFiber, Medical, Absorbent

Product Code Classifications

CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10612899001982PrimaryGS10
30612899001986Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1061289900198210612899001982
3061289900198630612899001986

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

Contacts

PhoneEmail
1-800-284-4540compliance@encompassgroup.net

Regulatory Flags

DUNS number
121788819
Device count
500
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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20612899005864EncompassG-P91602023-06-22

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