FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9167521000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD916752100
Catalog number
SD916752100
Device description
7 inch McCrea Infant & Female Sound, 8fr
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIGRETRACTOR, ALL TYPES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD9167521000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fixed-diameter cervical dilator, reusableA rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. 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
B382SD9226391030Surgical DirectSD922639103SD9226391032023-02-22
B382SD9192442700Surgical DirectSD919244270SD9192442702022-12-01
B382SD48155416201210Surgical DirectSD4815541620-121SD4815541620-1212022-11-30
B382SD180190Surgical DirectSD18019SD180192020-04-29
B382SD180290Surgical DirectSD18029SD180292020-04-28
B382SD182490Surgical DirectSD18249SD182492020-04-29
B382SD182590Surgical DirectSD18259SD182592020-04-25
B382S25681060Surgical DirectS2568.106S2568.1062026-07-29
B382S340861270Surgical DirectS34086.127S34086.1272026-07-29
B382SD90557818E0Surgical DirectSD90557818ESD90557818E2026-07-29
B382SD90712216T0Surgical DirectSD90712216TSD90712216T2026-07-29
B382SD914709040Surgical DirectSD91470904SD914709042026-07-29
B382SD919327220Surgical DirectSD91932720SD919327202026-07-29
B382SD919327230Surgical DirectSD91932723SD919327232026-07-29
B382SD919523070Surgical DirectSD91952307SD919523072026-07-29
B382SD919523080Surgical DirectSD91952308SD919523082026-07-29
B382SD9196141000Surgical DirectSD919614100SD9196141002026-07-29
B382SD9196141010Surgical DirectSD919614101SD9196141012026-07-29
B382SD9200321000Surgical DirectSD920032100SD9200321002026-07-29
B382SD9200321060Surgical DirectSD920032106SD9200321062026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858466005608POLYTRACTORDENTAMERICA, INC.EIG2026-07-27
00190776405946MillenniumAvalign Technologies, Inc.EIG2026-07-26
00190776405762MillenniumAvalign Technologies, Inc.EIG2026-07-24
00190776405793MillenniumAvalign Technologies, Inc.EIG2026-07-24
00190776403225MillenniumAvalign Technologies, Inc.EIG2026-07-19
00190776395599MillenniumAvalign Technologies, Inc.EIG2026-07-14
00840456223321JMUJMU DENTAL, INCEIG2026-07-07
00840456223338JMUJMU DENTAL, INCEIG2026-07-07
00840456223345JMUJMU DENTAL, INCEIG2026-07-07
00840456223352JMUJMU DENTAL, INCEIG2026-07-07
00840456200186JMUJMU DENTAL, INCEIG2026-07-06
08961104622197Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622203Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622210Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622227Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622234Lip RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622241Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622258Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622265Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622272Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622289Lip RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
10304040196998Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
10304040197001Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
10304040197018Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
G149NP260020NPSACME ENTERPRISE.EIG2026-05-01
G149NPORR0NPSACME ENTERPRISE.EIG2026-05-01
B382SD9144082080Surgical DirectSurgical Direct, Inc.EIG2026-02-12
B382SD9210921010Surgical DirectSurgical Direct, Inc.EIG2026-02-12
00190707191153Ortho Technology®Ortho Organizers, Inc.EIG2025-10-23
B382SD5615280Surgical DirectSurgical Direct, Inc.EIG2025-10-06