FDA.reportPublic FDA data

SUSI

Primary DI
04046963361747
Brand
SUSI
Company
Aesculap AG
Model
BT028SU
Catalog number
BT028SU
Device description
"ROUX SUSI Wound Retractor, 6 3/4"", (170 mm), double ended, 36 x 20 mm, 20 x 15 mm, sterile, disposable, pack of 20 pcs, single packed"
Published
2020-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963361747PrimaryGS10
04046963186432Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963361747040469633617474046963361747
04046963186432040469631864324046963186432

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, single-useA sterile, 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 single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
20
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964694165AESCULAPPL741SUPL741SU2016-09-23
04046964809392AESCULAPPL739SUPL739SU2016-10-10
04046964810411AESCULAPPL743SUPL743SU2016-10-10
04038653434022AESCULAPFT944TFT944T2015-09-24
04046963417468AESCULAPFT942TFT942T2015-09-24
04038653042586AESCULAPET251RET251R2016-09-23
04046964227547AESCULAPGF058BGF058B2016-09-23
04038653148998AESCULAPDO706RDO706R2020-04-21
04038653105878AESCULAPLS059RLS059R2020-04-21
04038653106080AESCULAPLS099RLS099R2020-04-21
04038653034666AESCULAPDE419RDE419R2020-06-17
04038653034697AESCULAPDE422RDE422R2020-06-17
04038653105977AESCULAPLS084RLS084R2022-07-29
04038653199020AESCULAPXG105RXG105R2021-10-15
04038653199006AESCULAPXG103RXG103R2020-08-24
04038653199013AESCULAPXG104RXG104R2020-08-24
04038653460533AESCULAPXG106RXG106R2020-08-24
04046963000431AESCULAPXG107RXG107R2020-08-24
04046963000448AESCULAPXG108RXG108R2020-08-24
04046963611538AESCULAPXG126RXG126R2020-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437145MillenniumAvalign Technologies, Inc.GAD2026-10-26
00190776437152MillenniumAvalign Technologies, Inc.GAD2026-10-26
00190776437169MillenniumAvalign Technologies, Inc.GAD2026-10-26
00190776439781MilleniumAvalign Technologies, Inc.GAD2026-10-26
00190776436957MillenniumAvalign Technologies, Inc.GAD2026-10-23
00190776437015MillenniumAvalign Technologies, Inc.GAD2026-10-23
00190776437022MillenniumAvalign Technologies, Inc.GAD2026-10-23
00840277134011Innomed, Inc.INNOMED, INC.GAD2026-10-22
00190776435615MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435622MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435660MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435707MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435714MillenniumAvalign Technologies, Inc.GAD2026-10-21
00724995323998V. MuellerSTERIS Deutschland GmbHGAD2026-10-21
00840338612656Made-To-OrderTORNIER, INC.GAD2026-10-21
00190776435578MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776435585MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776437787MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776439699MilleniumAvalign Technologies, Inc.GAD2026-10-20
B382SD907310070Surgical DirectSurgical Direct, Inc.GAD2026-10-20
00190776435219MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435233MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435264MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435301MillenniumAvalign Technologies, Inc.GAD2026-10-19
03661219011590LANDANGERLANDANGERGAD2026-10-19
G4533310960PEAK MEDICALPeak Medical Distribution Inc.GAD2026-10-19
00198506056529ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096075ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096082ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096099ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16