FDA.reportPublic FDA data

Kalitec Disc Prep

Primary DI
B07319K0861400
Brand
Kalitec Disc Prep
Company
Kalitec Direct LLC
Model
19-K08-6140
Catalog number
19-K08-6140
Device description
Pituitary, Straight, 3mm
Published
2020-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
B07319K0861400PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
041956211
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
B07315K0112220NIDO Pedicle Screw System15-K01-122215-K01-12222025-03-19
B07315K0112300NIDO Pedicle Screw System15-K01-123015-K01-12302025-03-19
B07315CLA50100NIDO Pedicle Screw System15-CLA-501015-CLA-50102024-09-19
B07315CLA51100NIDO Pedicle Screw System15-CLA-511015-CLA-51102024-09-19
B07330TNS27070Navagio Lumbar Cage30-TNS-270730-TNS-27072024-08-12
B07330TTS27070Navagio Lumbar Cage30-TTS-270730-TTS-27072024-08-12
B07311K0130400Cosmolock11-K01-304011-K01-30402024-06-20
B07315K0120120NIDO Pedicle Screw System15-K01-201215-K01-20122024-05-31
B07315K0120100NIDO Pedicle Screw System15-K01-201015-K01-20102024-05-02
B07315K0170000NIDO Pedicle Screw System15-K01-700015-K01-70002024-03-01
B07310BRS02300Cosmolock10-BRS-023010-BRS-02302024-01-16
B07315BCC05000NIDO Pedicle Screw System15-BCC-050015-BCC-05002023-10-06
B07315BCC05050NIDO Pedicle Screw System15-BCC-050515-BCC-05052023-10-06
B07315BCC05100NIDO Pedicle Screw System15-BCC-051015-BCC-05102023-10-06
B07315BCC05150NIDO Pedicle Screw System15-BCC-051515-BCC-05152023-10-06
B07315BCC05250NIDO Pedicle Screw System15-BCC-052515-BCC-05252023-10-06
B07315BCC05300NIDO Pedicle Screw System15-BCC-053015-BCC-05302023-10-06
B07315BCC05350NIDO Pedicle Screw System15-BCC-053515-BCC-05352023-10-06
B07315BCC05400NIDO Pedicle Screw System15-BCC-054015-BCC-05402023-10-06
B07315BCC05450NIDO Pedicle Screw System15-BCC-054515-BCC-05452023-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810055250189Surgical DesignSurgical Design, Inc.HTX2026-05-23
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00810189450516Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450547Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450554Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450561Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450578Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450585Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450592Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450608Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450615Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450622Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450639Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450646Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450653Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450660Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451322Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451339Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451346Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451353Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451360Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451377Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451384Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451391Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451407Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451414Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451520Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451544Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451551Surgical DesignSurgical Design, Inc.HTX2026-05-23