FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9140251010
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD914025101
Catalog number
SD914025101
Device description
Satterlee Saw Blade – Only
Published
2026-07-28
Public version status
New
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
GDRSaw, Manual And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDRSaw, Manual And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD9140251010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual surgical saw, rigidA hand-held manual surgical instrument typically used in orthopaedic surgery for cutting bone or other body tissue through a sawing action performed by the user. It typically consists of a metal frame with an attached handle that firmly holds an exchangeable blade usually with the cutting teeth set in a straight line; or it may have an integral blade as part of the design which can have a straight or curved cutting edge. 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
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

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