FDA.report

REPLCMNT BLADE FOR CRV/STR

Primary DI
D928107206CSK0
Brand
REPLCMNT BLADE FOR CRV/STR
Company
W.H. Holden, Inc.
Model
10-7206C/SK
Published
2023-11-05
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
MXPBONE PARTICLE COLLECTOR

Product Code Classifications

CodeDeviceSpecialtyClass
MXPBone Particle CollectorEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D928107206CSK0PrimaryHIBCC0

GMDN Terms

TermDefinition
Manual scalpel blade, reusableAn interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. The device is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. 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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D928105109JHF59DLC0CURETTE BONE #9J HF D/E SHORT HANDLE DLC10-5109JHF59DLC2026-01-06
D928105402HF0PERIOSTEAL ELEVATOR LANGER, MIRROR FINISH, HF D/E10-5402HF2026-01-06
D928105410CH0PERIOSTEAL ELEVATOR HOWARD #9H CH D/E10-5410CH2026-01-06
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00840105222392ZOLL DENTALZoll-DentalMXP2022-03-08
00840105200727ZOLL-DENTALZoll-DentalMXP2021-03-10
00840105200734ZOLL-DENTALZoll-DentalMXP2021-03-10
00840105200741ZOLL-DENTALZoll-DentalMXP2021-03-10
00840105202165ZOLL-DENTALZoll-DentalMXP2021-03-10