FDA.reportPublic FDA data

SBH

Primary DI
00850068304431
Brand
SBH
Company
SBH Surgical
Model
Bariatric Cross Bar
Catalog number
B02
Device description
"Bariatric Side Arm 1/2"""
Published
2026-05-11
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
PYHSurgical Retractor Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYHSurgical Retractor KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850068304431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850068304431008500683044318500683044310850068304431

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam 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
Serial number
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
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
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
00850068304424SBHSBH SurgicalPYH2026-05-11
00850068304448SBHSBH SurgicalPYH2026-05-11
14026704919243PILLINGTELEFLEX INCORPORATEDPYH2024-08-13
14026704919250PILLINGTELEFLEX INCORPORATEDPYH2024-08-13
14026704919267PILLINGTELEFLEX INCORPORATEDPYH2024-08-13
14026704918307PILLINGTELEFLEX INCORPORATEDPYH2024-07-15
54026704918305PILLINGTELEFLEX INCORPORATEDPYH2024-07-15
24026704450200PILLINGTELEFLEX INCORPORATEDPYH2018-09-15
24026704509137PILLINGTELEFLEX INCORPORATEDPYH2018-09-15
24026704515398PILLINGTELEFLEX INCORPORATEDPYH2018-09-15
24026704515404PILLINGTELEFLEX INCORPORATEDPYH2018-09-15
24026704515411PILLINGTELEFLEX INCORPORATEDPYH2018-09-15