FDA.report

Brasseler USA

Primary DI
00887919681007
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5023303U0
Device description
CP113NS6 GCP NS #6 HDL 1P
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EMDHEMOSTAT, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMDHemostat, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887919681007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919681007008879196810078879196810070887919681007

GMDN Terms

TermDefinition
Gauze packerA hand-held, surgical instrument used for introducing and packing gauze or dressings into body cavities. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
082080136
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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Other Devices Sharing Product Codes

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G1493807609TBS DentalACME ENTERPRISE.EMD2026-03-02
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00840343726287GEN2SURGIX MEDICAL LLCEMD2025-06-09
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00840343725884GEN2SURGIX MEDICAL LLCEMD2025-03-07
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