FDA.reportPublic FDA data

SurgiLock

Primary DI
00850047863027
Brand
SurgiLock
Company
Medicalock Corporation
Model
SLS1016
Catalog number
SLS1016
Device description
"Safety Instrument Platform, 10"" X 16"", Sterile"
Published
2024-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00850047863027PrimaryGS10
00850047863010Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047863027008500478630278500478630270850047863027
00850047863010008500478630108500478630100850047863010

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
6084302475jodie@medicalock.com

Regulatory Flags#

DUNS number
118863171
Device count
15
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850047863102SurgiLockSL10072024-07-30
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
00850047863263SurgiLockTrendelenburg Head PositionerSLFHPET2024-07-30
00850047863324SurgiLockTorso & Head Positioning KitSLFSHTPK2024-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380657530021ORA SYSTEM, VerifEyeAlcon Laboratories, Inc.PUI2026-07-22
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10198956353954CARDINAL HEALTHCardinal Health 200, LLCPUI2026-07-20
20193489029939MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
20193489029953MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
30193489028199MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
16931918102214AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918102948AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918107356AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
20193489108214MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
20888277636559MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
00628110259554MolecuLightDX Eco DarkDrapes (Case of 50)MolecuLight IncPUI2026-07-08
00628110259578MolecuLightDX DarkDrape Eco ClipMolecuLight IncPUI2026-07-08
06932523052430Equipment DrapeJiangSu MedPlus Non-Woven Manufacturer Co., LtdPUI2026-07-08
10304040193362Henry ScheinHENRY SCHEIN, INC.PUI2026-06-25
00748426263448Convertors®Microtek Medical LLCPUI2026-06-09
30680651501272HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501289HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501296HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501302HalyardO&M HALYARD, INC.PUI2026-06-08
16931918100876AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918102450AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104201AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104416AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104645AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104843AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104935AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918105239AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918106977AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04