FDA.reportPublic FDA data

SurgiLock

Primary DI
00850047863102
Brand
SurgiLock
Company
Medicalock Corporation
Model
SL1007
Device description
Instrument Platform, 10" X 7", Sterile
Published
2024-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850047863119PrimaryGS10
00850047863102Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047863119008500478631198500478631190850047863119
00850047863102008500478631028500478631020850047863102

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature32 Degrees Fahrenheit160 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6084302475jodie@medicalock.com

Regulatory Flags#

DUNS number
118863171
Device count
15
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850047863799SurgiLockAnterior Cervical Discectomy Fusion Positioning KiSLFACDFK2026-09-24
00850047863829SurgiLockLateral Lumbar Interbody Fusion KitSLFLLIFK2026-09-24
00850047863836CerviLockCerviLock Strap Kit w/ FoamCLSK-F2026-09-24
00850047863294SurgiLockLateral Thoracic KitSLFLTK2024-07-30
00850047863300SurgiLockGeneral Surgical Positioning KitSLFSHTPSPK2024-07-30
00850047863225SurgiLock"59"" Strap Pad"SLFPE59082024-07-30
00850047863621SurgiLockHeel Positioner SLFHEEL47K2025-12-01
00850047863317SurgiLockJelly Wrap Positioning Kit SLFJW1226K2024-07-30
00850047863515SurgiLock"20"" x 36"" Torso Pad"SLFPE20362025-03-27
00850047863454SurgiLockRobotics Positioning KitSLFSHTPJWK2025-02-11
00850047863287SurgiLock"20"" x 24"" Torso Pad (one side)"SLFP1E20242024-10-10
00850047863188SurgiLock"8"" x 10"" Pad"SLFPE08102024-10-10
00850047863218SurgiLock"24"" x 6"" Pad"SLFPE24062024-10-10
00850047863133Dentistry LockDentistry Lock PadDLP07552024-08-05
00850047863119SurgiLockSL10072024-07-30
00850047863157SurgiLock3 in 1 Head PositionerSLFHPE312024-07-30
00850047863195SurgiLock"20"" x 24"" Torso Pad"SLFPE20242024-07-30
00850047863201SurgiLock"20"" x 29"" Torso Pad"SLFPE20292024-07-30
00850047863232SurgiLockTapered Leg PadSLFTLPE32142024-07-30
00850047863249SurgiLockStandard Head PositionerSLFHPES2024-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160538999HalyardMEDICAL ACTION INDUSTRIES INC.PUI2026-09-24
10850091824002AeroKEEHealkee Medical USA Inc.PUI2026-09-24
10850091824019AeroKEEHealkee Medical USA Inc.PUI2026-09-24
10197344220083MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-09-18
10197344220090MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-09-18
00197998192814Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998304996Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305016Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305030Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305078Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305092Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305115Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305139Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305153Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312373Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312397Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312434Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312458Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312472Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312496Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329678Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329708Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329739Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329760Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329791Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329821Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329852Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330032Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330124Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330216Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23