FDA.reportPublic FDA data

SBH

Primary DI
00850068304219
Brand
SBH
Company
SBH Surgical
Model
SB 106.135E - Non Perforated Bot.
Catalog number
SB 106.135E
Device description
Sterlization Container, 1/1 bottom perforated 585x274x116 mm
Published
2025-02-20
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
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850068304219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850068304219008500683042198500683042190850068304219

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. 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
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
00850068304226SBHChroma - Blue 2mmG2W4271-82F 2025-08-11
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
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
00810166522809X-PACEXPANDING INNOVATIONS, INC.KCT2026-05-27
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07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177813MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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10197344177783MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
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