FDA.report

Surgical Instrument

Primary DI
08809539697192
Brand
Surgical Instrument
Company
OSTEONIC CO.,Ltd.
Model
Y1Z.22010
Published
2025-06-27
Public version status
New
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
FZXGuide, Surgical, Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809539697192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809539697192088095396971928809539697192

GMDN Terms

TermDefinition
Surgical instrument/implant depth limiter, reusableA device designed to limit the depth of insertion of a surgical instrument (e.g., a drill bit or a reamer), a trial implant, or an implant. It may be used as a stand-alone device or it may be attached to another device to control insertion depth, typically to prevent insertion below the surgical field of interest thereby avoiding damage to tissue behind or below target structures. It is typically made of high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
688999370
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
false
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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08800071022503SignexS3H.502602025-07-01
08800071022510SignexS3H.502802025-07-01
08800071022527SignexS3H.503002025-07-01
08800071022534SignexS3H.503202025-07-01
08800071022541SignexS3H.503402025-07-01
08800071022558SignexS3H.503602025-07-01
08800071022565SignexS3H.503802025-07-01
08800071022572SignexS3H.504002025-07-01
08800071022589SignexS3H.504202025-07-01
08800071022596SignexS3H.504402025-07-01
08800071022602SignexS3H.504602025-07-01

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09421038411971Dist Fem Cut Block Slot Connector – 10mmENZTEC LIMITEDFZX2026-02-27
09421038411988Dist Fem Cut Block – 1.27mmENZTEC LIMITEDFZX2026-02-27
09421038411995IM Rod – 8mm x 135mmENZTEC LIMITEDFZX2026-02-27