FDA.report

RONGEUR

Primary DI
00888118034366
Brand
RONGEUR
Company
KLS-Martin L.P.
Model
24-993-05-07
Published
2018-09-26
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

Related Records

Contact Domains

Product Codes

CodeName
HAERONGEUR, MANUAL
HTXRONGEUR

Product Code Classifications

CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2
HTXRongeurOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888118034366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118034366008881180343668881180343660888118034366

GMDN Terms

TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

Regulatory Flags

DUNS number
826499238
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

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00888118143266PURE PECTUS24-070-40-092026-03-23
00888118143273PURE PECTUS24-070-42-092026-03-23
00888118143280PURE PECTUS24-070-44-092026-03-23
00888118143297PURE PECTUS24-070-46-092026-03-23
00888118143303PURE PECTUS24-070-48-092026-03-23
00888118143310PURE PECTUS24-070-50-092026-03-23
00888118143327PURE PECTUS24-071-40-092026-03-23
00888118143334PURE PECTUS24-071-42-092026-03-23
00888118143341PURE PECTUS24-071-44-092026-03-23
00888118143358PURE PECTUS24-071-46-092026-03-23
00888118143365PURE PECTUS24-071-48-092026-03-23
00888118143372PURE PECTUS24-071-50-092026-03-23
00888118145321PURE PECTUS24-070-50-892026-03-23
00888118145338PURE PECTUS24-071-50-892026-03-23
00888118149671LEVEL ONE CMF, STERILE25-882-06-712026-03-23
00888118149701LEVEL ONE CMF, STERILE25-883-17-712026-03-23
00888118149718LEVEL ONE CMF, STERILE25-883-19-712026-03-23
00888118149725LEVEL ONE CMF, STERILE25-887-17-712026-03-23
00888118149732LEVEL ONE CMF, STERILE25-887-19-712026-03-23
00888118149749LEVEL ONE CMF, STERILE25-889-09-712026-03-23

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