FDA.reportPublic FDA data

Blumenthal Rongeur 30 Angle 16cm

Primary DI
G25012029300
Brand
Blumenthal Rongeur 30 Angle 16cm
Company
N S SURGICAL COMPANY
Model
12-029-30
Catalog number
12-029-30
Device description
A 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.
Published
2023-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
G25012029300PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length16Centimeter

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization"", ""Ultraviolet Light""]"
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light

Regulatory Flags#

DUNS number
645681649
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
G25011020030Fox Curettes11-020-0311-020-032023-03-27
G25001012200Taylor Hammer01-012-2001-012-202023-01-31
G25001013180Buck Hammer01-013-1801-013-182023-01-26
G25008007180Spurling Pitutiary Ronguer 4mm/18cm08-007-1808-007-182023-09-02
G25009069160Inge Spreader (Child) 16cm09-069-1609-069-162023-09-02
G25012083230Bone Hooks 23cm12-083-2312-083-232023-09-02
G25012102180Volkmann Curette 5.2mm/17cm Straight12-102-1712-102-172023-09-02
G25012191240Lambotte Osteotomes Straight 38mm12-191-2412-191-242023-09-02
G25012195240Lambotte Osteotomes Curved 13mm12-195-2412-195-242023-09-02
G25010005140Laborde Dilator Forcep10-005-1410-005-142023-04-29
G25003140150Debakey Forceps 1.5mm/15cm03-140-1503-140-152023-04-28
G25003168240Debakey Satinsky Forceps 24cm03-168-2403-168-242023-04-28
G25003178000Vasectomy Set of 203-178-0003-178-002023-04-29
G25008036030Penfield Elevator08-036-0308-036-032023-04-28
G25009006010Volkmann Retractor 1 Prong Sharp09-006-0109-006-012023-04-29
G25009047020Weitlaner Retractor 20cm Blunt 3x409-047-0209-047-022023-04-28
G25009047190Anderson Retractor 19cm Blunt 4x409-047-1909-047-192023-04-28
G25009050130Weitlaner Retractor 14cm Blunt09-050-1309-050-132023-04-28
G25010034030Killian Nasal Speculum 75mm/13cm10-034-0310-034-032023-04-29
G25010035010Cottle Nasal Speculum 35mm/15cm10-035-0110-035-012023-04-29

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Primary DI, Brand, Company table
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00190776432546MillenniumAvalign Technologies, Inc.HTX2026-09-28
00724995267902Snowden-PencerSTERIS Deutschland GmbHHTX2026-09-25
00724995274597V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321390V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321406V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321413V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321420V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00190776431105MillenniumAvalign Technologies, Inc.HTX2026-09-21
00190776427955MillenniumAvalign Technologies, Inc.HTX2026-08-27
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B382SD9227656000Surgical DirectSurgical Direct, Inc.HTX2026-08-21
00190776426682MillenniumAvalign Technologies, Inc.HTX2026-08-19
00190776426699MillenniumAvalign Technologies, Inc.HTX2026-08-19
B382SD922812030Surgical DirectSurgical Direct, Inc.HTX2026-08-07
00190776422912MillenniumAvalign Technologies, Inc.HTX2026-08-03
00190776422929MillenniumAvalign Technologies, Inc.HTX2026-08-03
B382SD4319D0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD480007LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD480046220Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482030LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482047PH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482058LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482505LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482506LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03