FDA.reportPublic FDA data

RONGEUR

Primary DI
00888118030252
Brand
RONGEUR
Company
KLS-Martin L.P.
Model
23-798-15-07
Device description
15CM, 6"
Published
2018-09-26
Public version status
Update
Distribution status
Not 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
EMHFORCEPS, RONGEUR, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMHForceps, Rongeur, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118030252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118030252008881180302528881180302520888118030252

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(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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118086037SILICONE MAT55-348-01-012020-06-19
00888118125729TRAY55-804-25-012020-06-19
00888118003119CARRIER00-105-92-072018-09-26
00888118006974CURETTE01-500-01-072018-09-26
00888118006981CURETTE01-500-02-072018-09-26
00888118006998CURETTE01-500-03-072018-09-26
00888118008626CALIPER04-407-20-072018-09-26
00888118009012SCOPE HOLDER ARM07-001-42-072016-09-20
00888118009029SCOPE HOLDER CLAMP07-001-43-072016-09-20
00888118009050SCOPE HOLDER ARM07-001-49-072016-09-20
00888118022950PHLEBEXTRACTOR16-249-02-072018-09-26
00888118022967PHLEBEXTRACTOR16-249-03-072018-09-26
00888118022981STRIPPER16-251-02-012018-09-26
00888118022998STRIPPER16-251-03-012018-09-26
00888118023001STRIPPER16-251-04-012018-09-26
00888118023018STRIPPER16-251-06-012018-09-26
00888118023025STRIPPER16-251-07-012018-09-26
00888118023032STRIPPER16-251-08-012018-09-26
00888118023049STRIPPER16-251-10-012018-09-26
00888118023056STRIPPER16-251-14-012018-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B7688452230Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.EMH2026-10-06
B7688452240Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.EMH2026-10-06
B76884751630Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.EMH2026-10-06
B7688632520Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.EMH2026-10-06
B7688652520Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.EMH2026-10-06
B76886844120Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.EMH2026-10-06
D955RON811S1Paul BandittTerlain Enterprises, Inc.EMH2026-09-25
D955RONBLU1Paul BandittTerlain Enterprises, Inc.EMH2026-09-25
D955RONMC0Paul BandittTerlain Enterprises, Inc.EMH2026-09-25
B76884850220Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-06-05
B7685631130Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-06-02
B7688371010Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-06-02
B7688386020Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-04-23
B7688441030Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-04-23
B76884751040Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-04-23
B76884754320Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-04-23
B7688441020Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-12-31
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B7688452420Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-11-03
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B76884850420Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884850520Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884852320Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884852420Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884852520Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B7685636870Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-23
B7685636880Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-23