FDA.reportPublic FDA data

NA

Primary DI
07611819792296
Brand
NA
Company
Synthes GmbH
Model
389.846
Catalog number
389846
Device description
CURVED PITUITARY/SOFT ANGLE 8MM WIDTH
Published
2016-12-31
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTRRASP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819792296Direct MarkingGS10
10705034776989PrimaryGS10
H9813898460SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819792296076118197922967611819792296
1070503477698910705034776989

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982350435NASD03.100.130SD031001302026-02-11
10886982350442NASD03.100.131SD031001312026-02-11
10886982350459NASD03.100.132SD031001322026-02-11
10886982350466NASD03.100.133SD031001332026-02-11
10886982351579NASD399.190SD3991902026-02-11
10886982351661NASD03.010.001SD030100012026-02-11
10886982351678NASD03.010.002SD030100022026-02-11
10886982361288NASD03.405.001SD034050012026-02-11
10886982361295NASD03.100.038SD031000382026-02-11
10887587078502NASD03.501.443SD035014432026-02-11
10887587078571NASD386.902SD3869022026-02-11
10886982351586NASD03.045.001SD030450012026-02-10
10886982351593NASD03.045.003SD030450032026-02-10
10886982362186NASD03.233.016SD032330162026-01-10
10886982362193NASD03.233.017SD032330172026-01-10
10886982362209NASD03.233.018SD032330182026-01-10
10886982362216NASD03.233.019SD032330192026-01-10
10886982361257VOLT60.529.210605292102025-12-16
H9810460002902S0NA04.600.029.02S0460002902S2019-08-20
H9810460002910S0NA04.600.029.10S0460002910S2019-08-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10889981443351SpecialsSeaspine Orthopedics CorporationHTR2026-03-03
10889981443368SpecialsSeaspine Orthopedics CorporationHTR2026-03-03
00190776416690MillenniumAvalign Technologies, Inc.HTR2026-02-16
03662663109574Mergence-A Preparation InstrumentationHighridge Medical, LLCHTR2026-02-11
00190376538969Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTR2026-02-10
00190376538976Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTR2026-02-10
03662663083720ActivLHighridge Medical, LLCHTR2026-02-03
03662663083737ActivLHighridge Medical, LLCHTR2026-02-03
03662663083744ActivLHighridge Medical, LLCHTR2026-02-03
00889024705524Identity 40MM Inset Humeral ProtectorZimmer, Inc.HTR2026-01-16
00840180543955General InstrumentsALPHATEC SPINE, INC.HTR2025-12-31
00840180545058General InstrumentsALPHATEC SPINE, INC.HTR2025-12-31
00888480490289Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490296Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
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00888480490388Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490395Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490401Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490418Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490425Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490432Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490449Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29