FDA.report

LIGATURE WIRE 30GA .010(4 OZ)

Primary DI
D9282011300
Brand
LIGATURE WIRE 30GA .010(4 OZ)
Company
W.H. Holden, Inc.
Model
20-1130
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
ECNCLAMP, WIRE, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECNClamp, Wire, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D9282011300PrimaryHIBCC0

GMDN Terms

TermDefinition
Wire ligatureA sterile, thin metal cord intended to be tied tightly around a blood vessel, the pedicle of a tumour, or other structure in order to constrict it. This is a single-use 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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