FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD571002EM0
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD57-10-02-EM
Catalog number
SD57-10-02-EM
Device description
"Pederson Vaginal Speculum, Medium, 4"" x 7/8"", Laser Black, with Slotted Smoke Disposable Evacuation Tube, Closed Side"
Published
2025-10-06
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
GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAFSpatula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD571002EM0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, reusableA hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 519-3293info@surgicaldirect.com

Regulatory Flags#

DUNS number
124367223
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD902511300Surgical DirectSD90251130SD902511302026-07-24
B382SD907394200Surgical DirectSD90739420SD907394202026-07-24
B382SD907581320Surgical DirectSD90758132SD907581322026-07-24
B382SD9141051110Surgical DirectSD914105111SD9141051112026-07-24
B382SD9141071020Surgical DirectSD914107102SD9141071022026-07-24
B382SD9141071030Surgical DirectSD914107103SD9141071032026-07-24
B382SD9141071040Surgical DirectSD914107104SD9141071042026-07-24
B382SD9141551000Surgical DirectSD914155100SD9141551002026-07-24
B382SD914172160Surgical DirectSD91417216SD914172162026-07-24
B382SD9141731000Surgical DirectSD914173100SD9141731002026-07-24
B382SD9141781300Surgical DirectSD914178130SD9141781302026-07-24
B382SD306090Surgical DirectSD30609SD306092022-11-23
B382SD155310120Surgical DirectSD15531012SD155310122026-07-23
B382SD155310140Surgical DirectSD15531014SD155310142026-07-23
B382SD1553600Surgical DirectSD155360SD1553602026-07-23
B382SD9017971040Surgical DirectSD901797104SD9017971042026-07-23
B382SD9029931060Surgical DirectSD902993106SD9029931062026-07-23
B382SD905701100Surgical DirectSD90570110SD905701102026-07-23
B382SD9114061030Surgical DirectSD911406103SD9114061032026-07-23
B382SD911424030Surgical DirectSD91142403SD911424032026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08961104622548Spatula 6mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
08961104622555Spatula 8.0 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
08961104622562Spatula 10 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
00840343727352GEN2SURGIX MEDICAL LLCGAF2026-04-16
10889950147624Hu-FriedyHU-FRIEDY MFG. CO., LLCGAF2026-02-24
00840018668164Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-02-10
00840018662810Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00840018662827Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00810158218420PRINCETONPrinceton Medical Group, Inc.GAF2026-01-07
B382SD9150391000Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391050Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391060Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150471120Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD915095250Surgical DirectSurgical Direct, Inc.GAF2025-12-29
08800075627766OSUNG MNDOSUNG MND Co., Ltd.GAF2025-11-03
00810158217652PRINCETONPrinceton Medical Group, Inc.GAF2025-10-17
00810158217669PRINCETONPrinceton Medical Group, Inc.GAF2025-10-17
B382SD572425E0Surgical DirectSurgical Direct, Inc.GAF2025-10-06
00810158217263PRINCETONPrinceton Medical Group, Inc.GAF2025-09-25
04250676741431SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
04250676741448SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
04250676741455SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
B382SD915095450Surgical DirectSurgical Direct, Inc.GAF2025-08-11
00840343725792GEN2SURGIX MEDICAL LLCGAF2025-06-16
00840343725808GEN2SURGIX MEDICAL LLCGAF2025-06-16
00840343725815GEN2SURGIX MEDICAL LLCGAF2025-06-16
10649111448614Sklar InstrumentsSKLAR CORPORATIONGAF2025-05-29
50649111448612Sklar InstrumentsSKLAR CORPORATIONGAF2025-05-29
B382SD915039100Surgical DirectSurgical Direct, Inc.GAF2025-05-19
B382SD915039120Surgical DirectSurgical Direct, Inc.GAF2025-05-19