FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD917665010
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD91766501
Catalog number
SD91766501
Device description
Alan-Parks Rectal Retractor, Set with 2 Pairs of Blades 80mm & 95mm
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD917665010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rectal speculumA hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. It is comprised of two arms joined at a pivot point and is available in various sizes, shapes, and contours; it is usually made of stainless steel. The instrument is used for examination or for the insertion of other instrumentation. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD134188100Surgical DirectSD13418-810SD13418-8102026-10-06
B382SD13798330Surgical DirectSD13798-33SD13798-332026-10-06
B382SD6520450Surgical DirectSD65-2045SD65-20452026-10-06
B382SD6562120Surgical DirectSD65-6212SD65-62122026-10-06
B382SD902866230Surgical DirectSD90286623SD902866232026-10-06
B382SD905582180Surgical DirectSD90558218SD905582182026-10-06
B382SD9056791090Surgical DirectSD905679109SD9056791092026-10-06
B382SD9056791170Surgical DirectSD905679117SD9056791172026-10-06
B382SD915598230Surgical DirectSD91559823SD915598232026-10-06
B382SD56534330Surgical DirectSD56534-33SD56534-332025-09-10
B382SD4830050Surgical DirectSD48-3005SD48-30052025-12-08
B382SD9141792000Surgical DirectSD914179200SD9141792002024-06-24
B382SD907186100Surgical DirectSD90718610SD907186102023-04-24
B382SD934496030Surgical DirectSD93449603SD934496032023-02-22
B382SD934496020Surgical DirectSD93449602SD934496022022-12-01
B382SD1618230Surgical DirectSD161823SD1618232022-11-23
B382SD161824530Surgical DirectSD16182453SD161824532022-11-23
B382SD413690Surgical DirectSD41369SD413692020-04-27
B382SD232590Surgical DirectSD23259SD232592020-04-25
B382SD9344181000Surgical DirectSD934418100SD9344181002026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10080196321452MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25