FDA.reportPublic FDA data

RONGEUR

Primary DI
00888118139061
Brand
RONGEUR
Company
KLS-Martin L.P.
Model
24-981-28-14
Device description
LAMINECTOMY, CASPAR, 30* UP, 5 MM JAWS, SB
Published
2022-11-25
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
HAERONGEUR, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118139061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118139061008881181390618881181390610888118139061

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118108357DISTRACTION, INTERNAL, STERILE51-556-20-812018-09-26
00888118108364DISTRACTION, INTERNAL, STERILE51-557-20-812018-09-26
00888118147226LEVEL ONE EXTREMITY26-950-64-042026-07-21
00888118147233LEVEL ONE EXTREMITY26-950-65-042026-07-21
00888118147240LEVEL ONE EXTREMITY26-950-66-042026-07-21
00888118147257LEVEL ONE EXTREMITY26-950-67-042026-07-21
00888118147264LEVEL ONE EXTREMITY26-950-68-042026-07-21
00888118147271LEVEL ONE EXTREMITY26-950-69-042026-07-21
00888118147714LEVEL ONE EXTREMITY26-950-58-042026-07-21
00888118147721LEVEL ONE EXTREMITY26-950-59-042026-07-21
00888118147738LEVEL ONE EXTREMITY26-950-62-042026-07-21
00888118147745LEVEL ONE EXTREMITY26-950-63-042026-07-21
00888118154620LEVEL ONE CMF25-315-92-912026-07-21
00888118154637LEVEL ONE CMF50-743-06-092026-07-21
00888118154644LEVEL ONE, STERILE25-433-97-712026-07-21
00888118154651LEVEL ONE, STERILE25-438-97-712026-07-21
00888118154668LEVEL ONE, STERILE25-439-91-712026-07-21
00888118154675LEVEL ONE, STERILE25-486-97-712026-07-21
00888118154682LEVEL ONE, STERILE25-487-97-712026-07-21
00888118154699LEVEL ONE, STERILE50-817-15-712026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995311759V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311766V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311865V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311872V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311889V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311964V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311971V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311988V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311995V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312008V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312015V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312077V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312084V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312091V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312107V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00190776432331MillenniumAvalign Technologies, Inc.HAE2026-09-24
04250325493537VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301713VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301720VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
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04255968301843VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301850VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301867VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301874VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301959VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301966VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301973VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22