FDA.report

SORBALUX DRAIN SPONGE ST 4X4 6PLY 600/CS

Primary DI
20612553017516
Brand
SORBALUX DRAIN SPONGE ST 4X4 6PLY 600/CS
Company
PAUL HARTMANN AG
Model
48800000
Device description
SORBALUX DRAIN SPONGE ST 4X4 6PLY 600/CS
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications

CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20612553017516PackageGS1300In Commercial Distribution
40612553017510PackageGS16In Commercial Distribution
10612553017519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2061255301751620612553017516
4061255301751040612553017510
1061255301751910612553017519

GMDN Terms

TermDefinition
Non-woven gauze pad, sterileA non-medicated sterile device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315768788
Device count
1
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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