FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9150391000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD915039100
Catalog number
SD915039100
Device description
Graves Weisman Speculum, Medium, Left open
Published
2025-12-29
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
B382SD9150391000PrimaryHIBCC0

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
B382SD484610Surgical DirectSD48461SD484612026-07-09
B382SD484630Surgical DirectSD48463SD484632026-07-09
B382SD484640Surgical DirectSD48464SD484642026-07-09
B382SD484650Surgical DirectSD48465SD484652026-07-09
B382SD484660Surgical DirectSD48466SD484662026-07-09
B382SD484670Surgical DirectSD48467SD484672026-07-09
B382SD484680Surgical DirectSD48468SD484682026-07-09
B382SD484690Surgical DirectSD48469SD484692026-07-09
B382SD484700Surgical DirectSD48470SD484702026-07-09
B382SD484710Surgical DirectSD48471SD484712026-07-09
B382SD484720Surgical DirectSD48472SD484722026-07-09
B382SD49400B0Surgical DirectSD49400BSD49400B2026-07-09
B382SD49401B0Surgical DirectSD49401BSD49401B2026-07-09
B382SD49402B0Surgical DirectSD49402BSD49402B2026-07-09
B382SD49403B0Surgical DirectSD49403BSD49403B2026-07-09
B382SD49404B0Surgical DirectSD49404BSD49404B2026-07-09
B382SD49405B0Surgical DirectSD49405BSD49405B2026-07-09
B382SD49406B0Surgical DirectSD49406BSD49406B2026-07-09
B382SD49407B0Surgical DirectSD49407BSD49407B2026-07-09
B382SD49408B0Surgical DirectSD49408BSD49408B2026-07-09

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
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
B382SD571002EM0Surgical DirectSurgical Direct, Inc.GAF2025-10-06
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