FDA.reportPublic FDA data

Gimmi

Primary DI
04049047040323
Brand
Gimmi
Company
Gimmi GmbH
Model
DA.1170.18
Catalog number
DA.1170.18
Device description
LOVE-GRUENWALD INTERVERTEBRAL DISC RONGESTRAIGHT, 3 X 10 MMLENGTH 180 MM
Published
2025-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049047040323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049047040323040490470403234049047040323

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497461965900contact@gimmi.de

Regulatory Flags#

DUNS number
316152610
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049047640868GimmiT.0120.62T.0120.622016-09-20
04049047640905GimmiT.0120.65T.0120.652017-05-05
04049047155324GimmiAD.1753.202026-06-08
04049047003137GimmiAA.1502.192026-05-18
04049047787815GimmiLIG.4148.30LIG.4148.302025-03-20
04049047788119GimmiLIG.4148.98LIG.4148.982025-03-20
04049047657545NAE.8230.48 LED2023-05-03
04049047657569GimmiE.8300.48 LEDE.8300.48 LED2023-02-14
04049047042563GimmiE.8230.45XE.8230.45X2017-05-05
04049047043164GimmiE.8300.35E.8300.352017-05-05
04049047043171GimmiE.8300.48E.8300.482017-05-05
04049047043430GimmiE.8997.00E.8997.002017-05-05
04049047043447GimmiE.8998.01E.8998.012017-05-05
04049047126379GimmiE.8230.41E.8230.412017-05-05
04049047127086GimmiE.8000.00E.8000.002017-05-05
04049047127246GimmiE.8230.45X SETE.8230.45X SET2017-05-05
04049047203322GimmiE.8300.45XE.8300.45X2017-05-05
04049047631675GimmiE.8998.02E.8998.022017-05-05
04049047643289GimmiE.8300.48X SETE.8300.48X SET2017-05-05
04049047064725GimmiM.1701.08M.1701.082025-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD914341100Surgical DirectSurgical Direct, Inc.HTX2026-07-13
B382SD9227021010Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD92270212C0Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707140Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707150Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707160Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707170Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707180Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707190Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922734060Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922734070Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922734080Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922738100Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227381000Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227381010Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227381020Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922738990Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD92274510120Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227771090Surgical DirectSurgical Direct, Inc.HTX2026-07-10
00810168190396NAPACIFIC INSTRUMENTS, INC.HTX2026-06-26
00198506091216ELMED INCORPORATEDELMED INCORPORATEDHTX2026-06-03
00846338005719ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005726ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005757ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005764ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005771ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005788ForcepsELLIQUENCE, LLCHTX2026-06-02
00810189451490Surgical DesignSurgical Design, Inc.HTX2026-05-29
09348811172174INKAThe Trustee for KAISER FAMILY TRUSTHTX2025-11-21
08809695610370AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.HTX2025-03-17