FDA.reportPublic FDA data

Senn Muller Retractor Sharp

Primary DI
G25009005010
Brand
Senn Muller Retractor Sharp
Company
N S SURGICAL COMPANY
Model
09-005-01
Catalog number
09-005-01
Device description
A hand-held, non-self-retaining 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 dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.
Published
2023-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
G25009005010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining 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 dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length16.5Centimeter

Sterilization Methods#

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

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

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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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B382SD209910FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209920FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209923FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907126105T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907247080T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907247112T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD90724711T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907249100Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907284670Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907337510Surgical DirectSurgical Direct, Inc.GAD2026-07-14
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00198506091872ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-10
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00810158219861PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00888937033687ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033694ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033700ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033717ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033724ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033731ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033748ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033755ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033762ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033779ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033786ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10