FDA.report

GAUZE PACKER & LIGATURE DIRECTOR D/E 3.0 mm STRAIGHT

Primary DI
D92820116010
Brand
GAUZE PACKER & LIGATURE DIRECTOR D/E 3.0 mm STRAIGHT
Company
W.H. Holden, Inc.
Model
20-1160-1
Published
2023-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EKGCONDENSER, AMALGAM AND FOIL, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKGCondenser, Amalgam And Foil, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D92820116010PrimaryHIBCC0

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
183854322
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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