FDA.reportPublic FDA data

SBH

Primary DI
00850068304226
Brand
SBH
Company
SBH Surgical
Model
Chroma - Blue 2mm
Catalog number
G2W4271-82F
Device description
"CHROMA STYLE KERRISON, BLUE, 8"", 10MM BITE, NO EJECTOR, 2MM *FLIP APART* "
Published
2025-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00850068304226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850068304226008500683042268500683042260850068304226

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.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
9493053300miguel@sbhsurgical.com

Regulatory Flags#

DUNS number
096823436
Device count
1
DM exempt
true
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
00850068304424SBHBariatric Table ClampBT012026-05-11
00850068304431SBHBariatric Cross BarB022026-05-11
00850068304448SBH"Bariatric Cross Bar 1/2"""G2W4271-83F2026-05-11
00850068304851SBHTrachea Hook ReusableSBH 55120-152026-05-08
00850068304233SBHChroma - Blue 3mmG2W4271-83F2025-08-11
00850068304257SBHER505.040E Non Perforated BottomER505.040E2025-06-16
00850068304264SBHER500.040E - Lid PerforatedER500.040E2025-06-16
00850068304271SBHER504.040E - Blue LidER504.040E 2025-06-16
00850068304288SBHER505.050E Non Perforated BottomER505.050E2025-06-16
00850068304240SBHSB 100.040E - Blue LidSB 100.040E2025-02-26
00850068304202SBHSB 106.100E Non Perforated BottomSB 106.100E2025-02-20
00850068304219SBHSB 106.135E - Non Perforated Bot.SB 106.135E2025-02-20
00850068304172SBHMF - Skull ClampSBH 117-000-402024-12-06
00850068304158SBHMF - Adjustable BaseSBH 117-000-15 2024-12-03
00850068304165SBHMF - Swivel AdaptorSBH 117-000-25 2024-12-03
00850068304189SBHMF - SystemSBH 117-000-10 2024-12-03
00850068304196SBHMF - Skull PinsSBH 117-000-54 2024-12-03
00850068304004SBHDental - 506.080ESB 506.080E2024-10-04
00850068304028SBHSingle Use - SBH 636560SBH 6365602024-10-04
00850068304035SBHSingle Use - 4311227SBH 43112272024-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9228132200Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132300Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132310Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132340Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132350Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132360Surgical DirectSurgical Direct, Inc.HTX2026-10-20
00190776435394MillenniumAvalign Technologies, Inc.HTX2026-10-19
00190776434670MillenniumAvalign Technologies, Inc.HTX2026-10-12
00190776434687MillenniumAvalign Technologies, Inc.HTX2026-10-12
00190776434113MillenniumAvalign Technologies, Inc.HTX2026-10-09
B382SD922779120Surgical DirectSurgical Direct, Inc.HTX2026-10-09
B382SD9228051950Surgical DirectSurgical Direct, Inc.HTX2026-10-09
00190776436360MillenniumAvalign Technologies, Inc.HTX2026-10-08
B382SD914800210Surgical DirectSurgical Direct, Inc.HTX2026-09-30
B382SD30550860Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD546210000Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD9228131060Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD9228131070Surgical DirectSurgical Direct, Inc.HTX2026-09-29
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
B382SD482012L0Surgical DirectSurgical Direct, Inc.HTX2025-10-06
00840217909327Wiggins MedicalEBNER MEDICAL, LLCHTX2024-12-09
00840217908924Wiggins MedicalEBNER MEDICAL, LLCHTX2024-03-21